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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer  Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
For Condition: Quality of Life,adenocarcinoma of the colon,recurrent rectal cancer,Stage 4 rectal cancer,recurrent colon cancer,adenocarcinoma of the rectum,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: I. Compare the efficacy and toxicity of high dose fluorouracil and leucovorin calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon or rectum. II. Compare progression free survival, overall survival, response rate, and duration of response in patients treated with these 2 regimens. III. Compare quality of life of patients treated with these 2 regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms: Arm I: Patients receive leucovorin calcium IV over 2 hours, followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive irinotecan IV over 30 minutes, followed by leucovorin calcium IV over 2 hours, followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Both arms: Treatment repeats every 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response are taken off study after receiving treatment for one year. Quality of life is assessed before beginning study, after completion of each course, at 4 weeks after completion of study, and then every 2 months until disease progression or death. Patients are followed every 2 months until disease progression or death. PROJECTED ACCRUAL: A total of 430 patients (215 per arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic adenocarcinoma of the colon or rectum - Measurable or evaluable disease outside of any prior radiation port - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for metastatic disease; No prior adjuvant chemotherapy containing topoisomerase I inhibitors; At least 6 months since other prior adjuvant chemotherapy - Endocrine therapy: Concurrent corticosteroids allowed - Radiotherapy: See Disease Characteristics - Surgery: Not specified - Other: At least 4 weeks since other prior investigational drugs; No other concurrent anticancer therapy --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (no greater than 1.5 times ULN if liver metastasis present); AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if liver metastasis present) - Renal: Creatinine no greater than 1.25 times ULN - Cardiovascular: No severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within the past 6 months - Gastrointestinal: No unresolved bowel obstruction or subobstruction; No uncontrolled Crohn's disease or ulcerative colitis; No history of chronic diarrhea - Other: No second malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer; No other uncontrolled severe medical condition; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Claus-HenningKoehne, Study Chair, EORTC Gastrointestinal Tract Cancer Cooperative Group
Kliniken Essen-Mitte
ESSEN, , D-45136
Germany
Institut Gustave Roussy
Villejuif, , F-94805
France
Internistisch - Onkologische Gemeinschaftspraxis
Halle, , D-06110
Germany
Klinikum Ernst Von Bergmann
Postdam, , D-14467
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
Medizinische Klinik I
Dresden, , D-01307
Germany
Allgemeines Krankenhaus der Stadt Wien
Vienna, , A-1090
Austria
Kreiskrankenhaus Aurich
Aurich, , D-26603
Germany
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Martin Luther Universitaet
Halle Saale, , DOH-0-6112
Germany
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , 115478
Russian Federation
Saint Laurentius Ziekenhuis
Roermond, , 6043 CV
Netherlands
Kreiskrankenhaus Riesa
Riesa, , D-01589
Germany
Haematology-Oncology
Braunschweig, , D-38100
Germany
Haematologisch-Oncologische Praxis
Koblenz, , D-56068
Germany
St. Johannes Hospital - Medical Klinik II
Duisburg, , D-47166
Germany
Ospedale San Lazzaro
Alba, , 12051
Italy
Krankenhaus Siloah - Medizinische Klinik II
Hannover, , D-30449
Germany
Klinikum Frankfurt (Oder)
Frankfurt (Oder), , D-15236
Germany
National Cancer Institute of Egypt
Cairo, ,
Egypt
Henriettenstiftung - Chirurgische Klinik
Hannover, , D-30171
Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , D-17487
Germany
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Muenchen Onkol. Praxis Elisenhof
Munich, , D-80335
Germany
PZB - Praxenzentrum
Aachen, , D-52062
Germany
Marienhospital/Ruhr University Bochum
Herne, , DOH-4-4625
Germany
Johannes Gutenberg University
Mainz, , D-55131
Germany
Evangelische Krankenhaus Hamm
Hamm, , DOH-5-9063
Germany
Otto-Von-Guericke-Universitaet Magdeburg
Magdeburg, , D-39120
Germany
Allgemeines Krankenhaus Hagen
Hagen, , D-58095
Germany
Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
Neustadt, , D-31533
Germany
Klinikum D. Ch. Erxleben
Quedlinburg, , D-06484
Germany
Praxis Innere Medizin
Neustadt, , D-01844
Germany
Marien Hospital
Hagen, , 58095
Germany
Staedtisches Klinikum Magdeburg
Magdeburg, , D-39002
Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , D-38440
Germany
Hermann-Holthusen Institute for Radiotherapy
Hamburg, , D-20099
Germany
Medizinische Poliklinik, Universitaet Wuerzburg
Wuerzburg, , D-97070
Germany
Fachkrankenhaus Marienstift
Schwarzenberg, , D-08340
Germany
Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
Wernigerode, , D-38843
Germany
Haemato-Onkol. Praxis
ESSEN, , 45127
Germany
Klinikum der Universitaet Ulm
Ulm, , D-89081
Germany
Stift Bethlehem
Ludwigslust, , D-19288
Germany
Haematologisch-Onkologische Praxis Altona
Hamburg, , D-22765
Germany
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Katharinenhospital
Stuttgart, , D-70174
Germany
Klinikum Lippe-Lemgo
Lemgo, , D-32657
Germany
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
University of Rostock
Rostock, , 18057
Germany
Humaine Klinik Dresden GmbH
Dresden, , 01326
Germany
Medical Oncology Centre of Rosebank
Johannesburg, , 2193
South Africa
Gemeinschaftspraxis
Worms, , DOH-6-7547
Germany
Universitatsklinik, Saarland
HOMBURG / SAAR, , D-66421
Germany
Eberhard Karls Universitaet
Tuebingen, , D-72076
Germany
Witten University - Klinikum Wuppertal
Wuppertal, , D-42283
Germany
Universitaetsklinik Duesseldorf
Duesseldorf, , D-40225
Germany
Hans-Susemihl-Krankenhaus
Emden, , D-26721
Germany
Additional Information:
Study ID Numbers: CDR0000067560; EORTC-40986
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004885
Other Quality Of Life Studies:
1. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Colorectal Cancer
4. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
5. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
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